LENALIDOMIDE GRINDEKS 2.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Lenalidomide Grindeks 2.5 mg hard capsules EFG

Lenalidomide Grindeks 5 mg hard capsules EFG

Lenalidomide Grindeks 7.5 mg hard capsules EFG

Lenalidomide Grindeks 10 mg hard capsules EFG

Lenalidomide Grindeks 15 mg hard capsules EFG

Lenalidomide Grindeks 20 mg hard capsules EFG

Lenalidomide Grindeks 25 mg hard capsules EFG

Lenalidomide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Lenalidomide Grindeks and what is it used for
2. What you need to know before you take Lenalidomide Grindeks
3. How to take Lenalidomide Grindeks
4. Possible side effects
5. Storage of Lenalidomide Grindeks
6. Contents of the pack and further information

1. What is Lenalidomide Grindeks and what is it used for

What isLenalidomide Grindeks

This medicine contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect how the immune system works.

What Lenalidomide Grindeks is used for

Lenalidomide is used in adults to:

• Multiple myeloma
• Follicular lymphoma

Multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cell called plasma cells. These cells build up in the bone marrow and multiply out of control. This can damage the bones and kidneys.

Multiple myeloma usually cannot be cured. However, the signs and symptoms can be greatly reduced or may disappear for a period of time. This is called "remission".

Newly diagnosed multiple myeloma: in patients who have undergone a bone marrow transplant, lenalidomide is used as maintenance treatment after recovery from the bone marrow transplant.

Newly diagnosed multiple myeloma: in patients who cannot be treated with a bone marrow transplant

Lenalidomide Grindeks is taken with other medicines, including:

• a chemotherapy medicine called "bortezomib";
• an anti-inflammatory called "dexamethasone";
• a chemotherapy medicine called "melphalan"; and
• an immunosuppressant called "prednisone".

You will take these medicines when you start treatment and then continue to take Lenalidomide Grindeks alone.

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Multiple myeloma: in patients previously treated

Lenalidomide is taken with an anti-inflammatory called "dexamethasone".

Lenalidomide may slow down the worsening of multiple myeloma symptoms. It has also been shown to delay the return of multiple myeloma after treatment.

Follicular lymphoma (FL)

FL is a slow-growing cancer that affects B lymphocytes. These are a type of white blood cell that helps the body fight infections. When someone has FL, they may have too many of these B lymphocytes in their blood, bone marrow, lymph nodes, and spleen.

Lenalidomide Grindeks is used with another medicine called "rituximab" in the treatment of adult patients who have received previous treatment for follicular lymphoma.

How Lenalidomide Grindeks works

Lenalidomide works by affecting the body's immune system and directly attacking the cancer. It works in several ways:

• stops the growth of cancer cells;
• stops the growth of blood vessels in the cancer;
• stimulates part of the immune system to attack cancer cells.

2. What you need to know before you take Lenalidomide Grindeks

You must read the package leaflet of all medicines you are going to take in combination with Lenalidomide before starting treatment with this medicine.

Do not take Lenalidomide Grindeks:

• if you are pregnant, think you may be pregnant or plan to become pregnant, as Lenalidomide is expected to be harmful to the fetus(see section 2, "Pregnancy, breastfeeding and contraception: information for women and men");
• if you can become pregnant, unless you follow all the necessary measures to avoid it (see section 2, "Pregnancy, breastfeeding and contraception: information for women and men"). If you can become pregnant, your doctor will record with each prescription that all necessary measures have been taken and will provide you with this confirmation;
• if you are allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If any of these conditions apply to you, do not take this medicine. In case of doubt, consult your doctor.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting Lenalidomide if:

• you have ever had blood clots; during treatment, you have a higher risk of developing blood clots in the veins and arteries;
• you have any signs of infection, such as cough or fever;
• you have or have previously had a viral infection, especially hepatitis B, varicella-zoster or HIV. If in doubt, consult your doctor. Treatment with lenalidomide may cause the virus to become active again in patients who carry the virus. This can lead to the return of the infection. Your doctor should check if you have ever had a hepatitis B infection;
• you have kidney problems; your doctor may adjust your dose of Lenalidomide Grindeks;
• you have had a heart attack, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels;
• you have had an allergic reaction while using thalidomide (another medicine used to treat multiple myeloma), such as skin rash, itching, swelling, dizziness or breathing problems;
• you have experienced in the past a combination of any of the following symptoms: widespread rash, skin redness, high body temperature, flu-like symptoms, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes (these are signs of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome).

If any of the above conditions apply to you, inform your doctor, pharmacist or nurse before starting treatment.

At any time, during or after treatment, inform your doctor or nurse immediately if you experience:

• blurred vision, loss of vision or double vision, difficulty speaking, weakness in an arm or leg, a change in the way you walk or balance problems, numbness, decreased sensitivity or loss of sensitivity, memory loss or confusion. These can be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you have any of these symptoms before starting treatment with lenalidomide, inform your doctor if you notice any change in these symptoms.
• Shortness of breath, tiredness, dizziness, chest pain, faster heartbeat or swelling in the legs or ankles. These can be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting treatment with Lenalidomide and during treatment, you will have regular blood tests. This is because Lenalidomide can cause a decrease in the blood cells that help fight infections (white blood cells) and those that help the blood to clot (platelets).

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 8 weeks of treatment;
• then at least every month.

You may be evaluated for signs of heart and lung problems before and during treatment with lenalidomide.

For patients with FL who take Lenalidomide Grindeks

Your doctor will ask you to have a blood test:

• before treatment;
• every week during the first 3 weeks (one cycle) of treatment;
• then every 2 weeks in cycles 2-4 (see section 3 for more information);
• after that, at the start of each cycle; and
• at least every month.

Your doctor may check if you have a high total tumor burden in your body, including the bone marrow. This could lead to a condition in which the tumors break down and produce unusual levels of chemicals in the blood, which can lead to kidney failure (this condition is called "tumor lysis syndrome").

Your doctor may examine you to check for changes in your skin, such as red spots or skin rashes.

Your doctor may adjust the dose of Lenalidomide or stop your treatment, depending on the results of your blood tests and your overall condition. If you are a newly diagnosed patient, your doctor may also evaluate your treatment based on your age and any other conditions you have.

Blood donation

You must not donate blood during treatment or for at least 7 days after the end of treatment.

Children and adolescents

Lenalidomide is not recommended for use in children and adolescents under 18 years.

Elderly people and people with kidney problems

If you are 75 years or older or have moderate to severe kidney problems, your doctor will monitor you closely before starting treatment.

Other medicines and Lenalidomide Grindeks

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because Lenalidomide Grindeks may affect how other medicines work. Also, some medicines may affect how Lenalidomide works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some medicines used to prevent pregnancy, such as oral contraceptives, as they may stop working;
• some medicines used for heart problems, such as digoxin;
• some medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception: information for women and men Pregnancy

Women taking Lenalidomide Grindeks

• You must not take Lenalidomide if you are pregnant, as it is expected to be harmful to the fetus.
• You must not become pregnant while taking Lenalidomide. Therefore, you must use effective contraceptive methods if you can become pregnant (see "Contraception").
• If you become pregnant during treatment with Lenalidomide, you must stop treatment and inform your doctor immediately.

Men taking Lenalidomide Grindeks

• If your partner becomes pregnant while you are taking Lenalidomide, you must inform your doctor immediately. It is recommended that your partner seeks medical advice.
• You must also use effective contraceptive methods (see "Contraception").

Breastfeeding

You must not breastfeed while taking Lenalidomide, as it is not known whether Lenalidomide passes into breast milk.

Contraception

For women taking Lenalidomide Grindeks

Before starting treatment, ask your doctor if you are able to become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you will have pregnancy tests under medical supervision (before each treatment, at least every 4 weeks during treatment and for at least 4 weeks after the end of treatment) unless it has been confirmed that your fallopian tubes have been blocked (tubal ligation);

And

• you must use effective contraceptive methods from at least 4 weeks before starting treatment, during treatment and for at least 4 weeks after the end of treatment. Your doctor will advise you on the most suitable contraceptive methods.

For men taking Lenalidomide Grindeks

Lenalidomide passes into human semen. If your partner is pregnant or can become pregnant and does not use any effective contraceptive method, you must use condoms during treatment and for at least 7 days after the end of treatment, even if you have had a vasectomy.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, drowsy, have vertigo or blurred vision after taking Lenalidomide Grindeks.

Lenalidomide Grindeks contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Lenalidomide Grindeks contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Lenalidomide Grindeks

Lenalidomide should be administered by a healthcare professional with experience in the treatment of multiple myeloma or FL.

• When Lenalidomide is used to treat multiple myeloma in patients who cannot be treated with a bone marrow transplant or have received previous treatments, it is taken with other medicines (see section 1 "What Lenalidomide Grindeks is used for").
• When Lenalidomide is used to treat multiple myeloma in patients who have received a bone marrow transplant, it is taken alone.
• When lenalidomide is used to treat follicular lymphoma, it is taken with another medicine called "rituximab".

Follow exactly the administration instructions of Lenalidomide indicated by your doctor. If in doubt, consult your doctor or pharmacist.

If you are taking Lenalidomide with other medicines, you should consult the package leaflet of those other medicines for additional information on their use and effects.

Treatment cycle

Lenalidomide is taken on certain days during a period of 3 weeks (21 days).

• A "treatment cycle" consists of 21 days.
• Depending on the day of the cycle, you will take one or more medicines. However, some days you will not take any medicine.
• After completing each 21-day cycle, you must start a new "cycle" during the next 21 days.

Or

Lenalidomide is taken on certain days during a period of 4 weeks (28 days).

• A "treatment cycle" consists of 28 days.
• Depending on the day of the cycle, you will take one or more medicines. However, some days you will not take any medicine.
• After completing each 28-day cycle, you must start a new "cycle" during the next 28 days.

How much Lenalidomide Grindeks to take

Before starting treatment, your doctor will tell you:

• how much Lenalidomide to take;
• how much of the other medicines to take with Lenalidomide, if any;
• which days of the treatment cycle to take each medicine.

How and when to take Lenalidomide Grindeks

• Swallow the capsules whole, preferably with water.
• Do not break, open or chew the capsules. If the powder from a broken Lenalidomide capsule comes into contact with your skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister or capsule. Then, they should carefully remove the gloves to avoid skin exposure, put them in a sealable polyethylene plastic bag and dispose of them according to local requirements. After that, they should wash their hands thoroughly with water and soap. Pregnant or possibly pregnant women should not handle the blister or capsule.
• The capsules can be taken with or without food.
• You should take lenalidomide at approximately the same time on the scheduled days.

Taking this medicine

To remove the capsule from the blister:

• Press only one end of the capsule to make it come out through the foil.
• Do not press in the center of the capsule as it may break.

Duration of treatment with Lenalidomide Grindeks

Lenalidomide is taken in treatment cycles, each cycle lasts 21 or 28 days (see "Treatment cycle" above). You should continue treatment cycles until your doctor tells you to stop treatment.

If you take more Lenalidomida Grindeks than you should

If you take more Lenalidomida than prescribed, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lenalidomida Grindeks

If you forget to take Lenalidomida at your usual time and

• less than 12 hours have passed: take the capsule immediately;
• more than 12 hours have passed: do not take the capsule. Take the next capsule the following day at the usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop treatment with Lenalidomida Grindeks and go to your doctor immediately because you may need urgent medical treatment:

• Hives, rash, swelling of the eyes, mouth or face, difficulty breathing or itching, which can be symptoms of serious allergic reactions called angioedemaand anaphylactic reaction.
• A severe allergic reaction that can start as a rash in one area, but spreads with significant skin loss throughout the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as "DRESS" or "drug-induced hypersensitivity syndrome"). See also section 2.

Consult your doctor immediately if you notice any of the following serious side effects:

• Fever, chills, sore throat, cough, mouth ulcers, or any other symptom of infection, including in the bloodstream (sepsis)
• Bleeding (bleeding) or hematoma (bruise) not due to an injury
• Chest pain (thoracic) or in the legs
• Difficulty breathing
• Bone pain, muscle weakness, confusion, or fatigue, which may be due to high levels of calcium in the blood.

Lenalidomida Grindeks may reduce the number of white blood cells that fight infections and also the blood cells that help blood clotting (platelets), which can cause bleeding disorders, such as nosebleeds and bruising. Lenalidomida Grindeks can also cause blood clots in the veins (thrombosis).

Other side effects

It is important to note that a small number of patients may develop other types of cancer, and this risk may increase with lenalidomida treatment. Therefore, your doctor should carefully evaluate the benefits and risks when prescribing lenalidomida.

Very common side effects(may affect more than 1 in 10 people):

• A decrease in the number of red blood cells, which can cause anemia, leading to fatigue and weakness.
• Rash, itching
• Muscle cramps, muscle weakness, muscle pain, muscle soreness, bone pain, joint pain, back pain, pain in the limbs
• Generalized swelling, including swelling of the arms and legs
• Weakness, fatigue
• Fever and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough, and chills
• Numbness, tingling, or burning sensation in the skin, pain in the hands or feet, dizziness, tremors
• Decreased appetite, changes in taste
• Increased pain, tumor size, or redness around the tumor
• Weight loss
• Constipation, diarrhea, nausea, vomiting, stomach pain, heartburn
• Low levels of potassium, calcium, or sodium in the blood
• Underactive thyroid function
• Leg pain (which could be a symptom of thrombosis), chest pain, or difficulty breathing (which could be a symptom of blood clots in the lungs, called pulmonary embolism)
• Infections of all kinds, including sinus infection, lung infection, and upper respiratory tract infection
• Difficulty breathing
• Blurred vision
• Eye opacity (cataracts)
• Kidney problems, including insufficient kidney function or inability to maintain normal kidney function
• Abnormal liver test results
• High liver test results
• Changes in a blood protein that can cause artery swelling (vasculitis)
• Increased blood sugar levels (diabetes)
• Decreased blood sugar levels
• Headache
• Nosebleeds
• Dry skin
• Mood changes, difficulty sleeping
• Cough
• Low blood pressure
• A vague feeling of bodily discomfort, feeling unwell
• Painful, inflamed mouth, dry mouth
• Dehydration

Common side effects(may affect up to 1 in 10 people):

• Destruction of red blood cells (hemolytic anemia)
• Certain types of skin tumors
• Bleeding from the gums, stomach, or intestines
• Increased or decreased blood pressure, slow, fast, or irregular heartbeat
• Increased amount of a substance produced after normal or abnormal destruction of red blood cells
• Increased levels of a protein that indicates the presence of inflammation in the body
• Darkening of the skin, skin discoloration due to internal bleeding, and bruising
• Increased uric acid in the blood
• Skin rash, skin redness, cracked skin, scaling, or peeling of the skin
• Increased sweating, night sweats
• Difficulty swallowing, sore throat, difficulty maintaining voice quality, or changes in voice
• Runny nose
• Strong increase or decrease in urine output or inability to control urination
• Blood in the urine
• Difficulty breathing, especially when lying down (which could be a symptom of heart failure)
• Difficulty having an erection
• Stroke, fainting, dizziness (a disorder of the inner ear that causes a sensation of spinning), temporary loss of consciousness
• Chest pain that spreads to the arms, neck, jaw, back, or stomach, sensation of sweating and shortness of breath, sensation of illness or vomiting, which can be symptoms of a heart attack (myocardial infarction)
• Muscle weakness, lack of energy
• Neck pain, chest pain
• Chills
• Joint swelling
• Slower or blocked bile flow from the liver
• Low levels of phosphate or magnesium in the blood
• Liver damage
• Balance disturbance, difficulty moving
• Deafness
• Ringing in the ears (tinnitus)
• Excess iron in the body
• Thirst
• Confusion
• Toothache
• Falls that can cause injuries

Uncommon side effects(may affect up to 1 in 100 people):

• Bleeding inside the skull
• Circulatory problems
• Vision loss
• Loss of sexual desire (libido)
• Excretion of large amounts of urine with bone pain and weakness, which can be symptoms of a kidney disorder (Fanconi syndrome)
• Yellowing of the skin, mucous membranes, or eyes (jaundice), pale stools, dark urine, itching, rash, pain, or swelling of the stomach (these symptoms may indicate liver damage [liver failure])
• Stomach pain, abdominal swelling, or diarrhea, which can be symptoms of inflammation of the large intestine (called colitis or typhlitis)
• Kidney cell damage (called renal tubular necrosis)
• Changes in skin color, sensitivity to sunlight
• Tumor lysis syndrome: metabolic complications can occur during cancer treatment and, in some cases, even without treatment. These complications occur as a result of the breakdown products of dying cancer cells and can include changes in blood biochemistry, high levels of potassium, phosphorus, and uric acid, and low levels of calcium, which can cause changes in kidney function and heart rhythm, crisis, and sometimes death
• Increased blood pressure in the blood vessels that supply the lungs (pulmonary hypertension)

Frequency not known(cannot be estimated from the available data):

• Sudden, mild, or severe pain in the upper abdomen and/or back that lasts for several days, possibly accompanied by nausea, vomiting, fever, and rapid pulse. These symptoms may be due to pancreatitis
• Wheezing or whistling when breathing, difficulty breathing, or dry cough, which can be symptoms caused by inflammation of the lung tissue
• Rare cases of muscle breakdown (pain, weakness, or swelling of the muscles) that can lead to kidney problems (rhabdomyolysis) have been observed, some of which occurred when lenalidomida was administered with a statin (a type of cholesterol-lowering medication)
• A disease that affects the skin caused by inflammation of small blood vessels, accompanied by joint pain and fever (leukocytoclastic vasculitis)
• Rupture of the stomach or intestine wall. This can lead to a severe infection. Inform your doctor if you have severe stomach pain, fever, nausea, vomiting, blood in the stool, or changes in bowel habits
• Viral infections, including herpes zoster (also known as shingles, a viral disease that causes a painful rash with blisters) and the recurrence of hepatitis B infection (which can cause yellowing of the skin and eyes, dark urine, stomach pain on the right side, fever, and nausea or feeling sick)
• Widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug-induced hypersensitivity syndrome). Stop using lenalidomida if you develop these symptoms and contact your doctor or seek immediate medical attention. See also section 2

• Rejection of solid organ transplants (such as kidney, heart)

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of Lenalidomida Grindeks

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiration date stated on the blister and carton after "EXP". The expiration date is the last day of the month indicated

This medicine does not require special storage conditions

Do not use this medicine if you notice visible signs of deterioration or signs of tampering

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment

6. Contents of the pack and further information

Composition of Lenalidomida Grindeks

Lenalidomida Grindeks 2.5 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 2.5 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue 1 E133, and yellow iron oxide (E172)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Lenalidomida Grindeks 5 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 5 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin and titanium dioxide (E171)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Lenalidomida Grindeks 7.5 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 7.5 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Lenalidomida Grindeks 10 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 10 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue 1 E133, and yellow iron oxide (E172)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Lenalidomida Grindeks 15 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 15 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin, titanium dioxide (E171), and brilliant blue FCF - FD&C Blue 1 E133
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Lenalidomida Grindeks 20 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 20 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin, titanium dioxide (E171), brilliant blue FCF - FD&C Blue 1 E133, and yellow iron oxide (E172)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Lenalidomida Grindeks 25 mg hard capsules:

• The active ingredient is lenalidomida. Each capsule contains lenalidomida ammonium, which is equivalent to 25 mg of lenalidomida
• The other ingredients are:

• Capsule content: lactose (see section 2), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate
• Capsule shell: gelatin and titanium dioxide (E171)
• Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172), and concentrated ammonia solution (E527)

Appearance of the product and pack contents

The Lenalidomida Grindeks 2.5 mg hard capsules are size 4, light green/white, with the inscription "L2.5"

The Lenalidomida Grindeks 5 mg hard capsules are size 4, white, with the inscription "L5"

The Lenalidomida Grindeks 7.5 mg hard capsules are size 3, light yellow/white, with the inscription "L7.5"

The Lenalidomida Grindeks 10 mg hard capsules are size 2, light green/pale yellow, with the inscription "L10"

The Lenalidomida Grindeks 15 mg hard capsules are size 1, blue/white, with the inscription "L15"

The Lenalidomida Grindeks 20 mg hard capsules are size 0, light green/blue, with the inscription "L20"

The Lenalidomida Grindeks 25 mg hard capsules are size 0, white, with the inscription "L25"

The capsules are presented in packs of 7 or 21 capsules per pack

Only some pack sizes may be marketed

Marketing authorization holder and manufacturer

AS GRINDEKS. Krustpils iela 53, Riga, LV-1057, Latvia Tel: +371 67083205 Fax: +371 67083505 e-mail: grindeks@grindeks.lv

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 - 2º Dcha

Madrid, 28003, Spain

This medication is authorized in the countries of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Date of the last revision of this prospectus:02/2022

Other sources of information

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)